Recalls / —
—#122642
Product
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- all lots of part no. 03.802.039
Why it was recalled
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Recalling firm
- Firm
- Synthes USA HQ, Inc.
- Address
- 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and Internationally to Canada .
Timeline
- Recall initiated
- 2013-10-08
- Posted by FDA
- 2013-11-27
- Terminated
- 2016-08-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #122642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.